Randox Lipoprotein — Class II medical device recall Z-1017-2025
Ongoing recall by Randox Laboratories, Limited, reported 2025-01-29, distributed nationwide. Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
| Recall number | Z-1017-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories, Limited, Crumlin, United Kingdom |
| Recall initiated | 2024-12-20 |
| Classified | 2025-01-23 |
| Reported by FDA | 2025-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 15 kits |
| UPC / GTIN / UDI-DI | 05055273204421 |
| Model numbers | LP3403 |
Product
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Reason for recall
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1017-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.